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Tuesday, November 14, 2006

Aleve Heart-Healthy Over Short-Term

(HealthDay News) -- Short-term use of Aleve, the over-the-counter version of the prescription painkiller naproxen, appears safe and even healthy for users' cardiovascular systems, a new company-funded study suggests.

Aleve falls into the category of drugs known as non-steroidal anti-inflammatory drugs (NSAIDs), which also includes analgesics such as aspirin, ibuprofen and cox-2 inhibitors such as Celebrex, Bextra and Vioxx. Bextra and Vioxx were pulled from the market after studies uncovered a significant rise in risk for cardiovascular events in people using cox-2s over the long term.

Use of Aleve -- at least over the short-term -- does not carry such risks, according to evidence from a small trial testing the drug's effects over a week of use. The trial was funded by Bayer, the maker of Aleve.

In fact, taking the medicine each day appears to reduce blood platelet activity in the same way that daily low-dose aspirin does, the study found. Accumulated platelets can build up in arteries, raising risks for heart attack or stroke.

"Patients come into my office and want something for pain," said lead investigator Dr. Michael Schiff, who treats patients at the Denver Arthritis Clinic and is also clinical professor of medicine at the University of Colorado School of Medicine. "They want to know if the medicine I am going to give is going to have a cardiovascular risk."

"This data speaks to that issue," he continued. "Aleve will not be risky in that sense, and it could be cardio-protective."

The findings were presented Monday at the annual meeting of the American College of Rheumatology, in Washington, D.C.

Ever since Vioxx and Bextra were withdrawn from the market, the question of the cardiovascular effects of other NSAIDs has come to the forefront.

In their study, Schiff's team enrolled 41 healthy adult men and women who were randomized to either Aleve twice-daily (220 milligram pill twice/day), Aleve three times daily, prescription naproxen twice-daily (total dose 1,100 milligrams/day), or a placebo.

At the end of the seven days, each person waited at least six days before taking daily low-dose aspirin (81 milligrams) for another seven days, for comparison purposes.The researchers then measured key blood and urine marker to detect signs of platelet inhibition.

They found that both doses of Aleve achieved an anti-platelet effect of 98 to 99 percent, similar to that achieved by the prescription form of the drug and low-dose aspirin.

"We know that the gastrointestinal side-effects of naproxen go down with a lower dosing," Schiff said. "So, this is good news for Aleve users who take a lower dose of the drug in its OTC form. They will get the same cardio-protective effects as with the prescription dose of the drug."

However, compared to the "gold-standard" of research -- a large, randomized clinical trial -- this study is rather small. "This was a laboratory study with small numbers relative to a large clinical trial," Schiff said. "But the blood-urine marker we used provided enough 'power' to the study to let us come to the conclusions we have reached. Further formal clinical studies will be needed to fully establish the cardio-protective implications of this study."

"The main point of the study is that OTC naproxen has similar anti-platelet effects as prescription-strength naproxen," added Dr. Arthur Kavanaugh, a rheumatology expert at the University of California, San Diego. He was not involved in the study.

"This is not surprising, but it is important because patients often think that OTC medications are less effective than their prescription counterparts," Kavanaugh said. "This study suggests that this is not the case for naproxen."

Prescription-strength naproxen has been available for over 30 years in the United States. The lower-strength version of the drug has been available without prescription since 1994.